PMA P800036S015

Device: INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4
Applicant: Intera Oncology
PMA number: P800036
Supplement: S015
Product code: LKK
Decision date: 1995-09-20
Generic name: Pump, infusion, implanted, programmable
Approval order statement: APPROVAL FOR CHANGE IN LABELING TO INCLUDE EPIDURAL AND INTRATHECAL ADMINISTRATION OF INFUMORPH 200 & 500 CII (PRESERVATIVE-FREE MORPHINE) IN PATIENTS SUFFERING FROM SEVERE AND PROLONGED PAIN WHO ARE NO LONGER RESPONSIVE TO CONVENTIONAL FORMS OF ANALGESIA

Current openFDA PMA Record#

Device: INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4
Applicant: Intera Oncology
PMA number: P800036
Supplement: S015
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 1995-09-20
Decision code: APPR
Date received: 1987-09-16
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGE IN LABELING TO INCLUDE EPIDURAL AND INTRATHECAL ADMINISTRATION OF INFUMORPH 200 & 500 CII (PRESERVATIVE-FREE MORPHINE) IN PATIENTS SUFFERING FROM SEVERE AND PROLONGED PAIN WHO ARE NO LONGER RESPONSIVE TO CONVENTIONAL FORMS OF ANALGESIA